Outsourcing in Clinical Trials Europe 2014

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1 TIME TO BUST E-RECRUITMENT MYTHS! Outsourcing in Clinical Trials Europe May 2014, Brussels, Belgium

2 you not only saved us a couple of months time, but definitively disproved two myths that have kept us very skeptical 1 st Online patient recruitment doesn't work internationally 2 nd Online advertising will not randomize a large number of patients 2

3 USA EUROPE Canada USA Mexico Brazil Argentina Chile Colombia - NEW % of business Germany Switzerland Austria France Spain (Portugal) Netherlands Belgium Italy UK Ireland - NEW Denmark Sweden Finland Norway - NEW Poland Czech Republic Russia Hungary Latvia Estonia (Romania) Ukraine - NEW % of business 1 st Question = HOW? 1 st Question = WHAT?? well established very experienced low acceptance low experience Israel Turkey India Japan Korea, South - NEW South Africa Australia New Zealand - NEW Industries attitude towards patient recruitment services 3

4 ...my patients aren't on the internet we've already done online recruitment and it doesn't work sites don't like it, low quality of patients online patient recruitment only works in certain countries...a sales conversation 4

5 patients aren't on the internet North America Regional Facts Internet Usage and Population Statistics for North America Population (in Millions) Internet Usage (in Millions) % Population (Penetration) Facebook (in Millions) Canada 34,3 28, % 18,1 Mexico 114,9 42,0 36,5 % 38,5 United States 313,8 245, % 166,0 TOTAL 463,0 316,0 68,3 % 222,6 5

6 patients aren't on the internet EUROPE Regional Facts Internet Usage and Population Statistics for Europe Population (in Millions) Internet Usage (in Millions) % Population (Penetration) Facebook (in Millions) TOTAL 820,9 M 518,5 M 63,2 % 250,9 M Russia 142,5 M 67,9 M 47,7 % 8,0 M Monaco 30,510 30, ,6 % 36,220 Vatikan City ,7 % 20 6

7 patients aren't on the internet Asia Regional Facts Internet Usage and Population Statistics for Asia Population (in Millions) Internet Usage (in Millions) % Population (Penetration) Facebook (in Millions) TOTAL 3,922 1,076 27,2 % 254,3 China 1, ,0 40,1 % 633,3 Korea, South 48,9 40,3 82,5 % 10,0 India 1, ,0 11,4 % 62,7 7

8 patients aren't on the internet Germany Austria France Spain Netherlands Belgium Italy UK Denmark Sweden Poland Czech Republic Russia Hungary Canada USA Mexico Brazil Argentina Top 25 Countries (CT.gov)* Internet Usage and Population Statistics for Top 25 countries Population (in Millions) Internet Usage (in Millions) % Population (Penetration) TOTAL 1, ,8 63,1 % excl. China / Taiwan *(Recruiting Excl. Unknown Interventional Studies Adult, Senior Phase 2, 3, 4 Industry) = 77% of global recruiting trials Israel Japan Korea, South China / Taiwan Australia 8

9 REFERRALS Time to bust e-recruitment myths! patients aren't on the internet MDD 12 Countries 1 Y CVD 14 Countries 3 M AD 1 Country (NA) 6 M 2,3 Million Responses 1,8 Million Responses 0,6 Million Responses 30,067 Registrations 9,828 Referrals 2,665 Scheduled 572 Enrolled , CALENDER WEEKS 1,257 1,203 1,139 1,046 2,990 Registrations 570 Referrals 190 Scheduled 94 Enrolled 9

10 e-recruitment doesn't work...my patients aren't on the internet we've already done online recruitment and it doesn't work sites don't like it, low quality of patients online patient recruitment only works in certain countries Agenda 10

11 e-recruitment doesn't work Tactic Channel % of Conversions Search Engine Marketing (SEM i.e. AdWords) 10% of conversions Display-Marketing (Banner) 60% of conversions Social Media (Banner / Text) 20% of conversions Database- / Affiliate-Marketing Subjects who have opted into receive s about a specific disease 10% of conversions What's e-recruitment / online patient recruitment for you? 11

12 e-recruitment doesn't work Develop and optimize online media campaign Example: Targeted on region of the site (i.e. Brussels, 1.9 million user) Population, total = 10.4 million Internet penetration = 77.8% (8.1 million user) Social media / Facebook = 42.3% (4.4 million user) Top websites visited differ in each country 12

13 e-recruitment doesn't work Advertising targeted to people around the clinical trial center Using internet protocol (IP) information, ads can be limited to a specific area Radius can be increased/decreased depending on the population in the area Sites provide input on the size of the advertising radius Reduces the number of subjects submitting referrals from too far away 13

14 e-recruitment doesn't work HC-Profs. Print Advertising Patient Organizations Direct Mailing Call Center Screening SMO Enrolled Hospital Patients & Relatives SEM Google etc. Social Media Information Tracking Reporting Banner Advertising Registration Online Screening Practice Online Awareness Campaign Website Pre- Screening Referral Enrollment It works! But only if you track every single step constantly! 14

15 e-recruitment doesn't work HC-Profs. Print Advertising Patient Organizations Direct Mailing Call Center Screening SMO Enrolled Hospital Patients & Relatives SEM Google etc. Social Media Information Tracking Reporting Banner Advertising Registration Online Screening Practice Online Awareness Campaign ClinLife Study Website Pre- Screening Referral Enrollment Marketing Report Registration & Funnel Call Center & Screening Report Site Activity Report Optimization 15

16 e-recruitment doesn't work In April 2008 we started to track outcome of EC / IRB submissions for: campaigns & materials designed by Clariness the respective authorities in 33 countries a total of 187 submissions until 2014 SEM Messages / AdWords / Banner Call Center Scripts Landing Pages / Study Descriptions Content etc. AND Data Protection Measures Approved = 174 of % (1 st submission) Average time to approval = 23 days Croatia - Advertising not accepted Romania - Advertising not accepted Slovakia - Advertising not accepted Portugal - Advertising not accepted Online advertising / recruitment will not be accepted by ECs / IRBs! 16

17 ...my patients aren't on the internet we've already done online recruitment and it doesn't work sites don't like it, low quality of patients online patient recruitment only works in certain countries Agenda 17

18 sites don t like it 361 of 1,564 invited investigators started to fill out the survey (23.1%) 242 participants completed the whole survey (15.5% and 67%, respectively) The survey participants are located in 18 countries, although 65.7% are from the US and Germany The survey had a maximum of 64 questions, depending on certain answers (Avg. time to complete: 17:25 min) The survey was available in 4 languages: EN, DE, PL, and ES 12% of the invitations were sent to non-native speakers in English. This had no statistical effect on completion rate Site Survey

19 sites don t like it Green bars are above average rate of completed survey per invitations (15.5%) Receiving the survey invitation in native language had no impact Strictly Confidential 19

20 sites don t like it Site type of survey participants (n = 242) Completed by site type Site type Completed Percent SMO 60 24,8% Hospital, total ,0% Hospital, University 65 26,9% Hospital, Governmental 18 7,4% Hospital, Private 21 8,7% Private practice 74 30,6% Other 4 1,7% Strictly Confidential 20

21 sites don t like it Time worked on trials per week (n = 242) 5 h 6-10 h h h h h h h 40 h 80.6% When do you manage clinical trials? (n = 242) While >80% work only half-time or less (<20h) on clinical trials, more than half state that they work on clinical trials exclusively Strictly Confidential 21

22 sites don t like it Average no. of simultaneous trials (n = 242) 120 How do you decide which trials to prefer? (n = 121; MC) to 3 4 to or more Strictly Confidential 22

23 sites don t like it Would you recommend using Online Recruitment? (n = 242) By background: MD vs. other (n = 242) Strictly Confidential 23

24 sites don t like it Step ❶ Online Awareness Campaign Step ❷-❸-❹-❺ Online- / Call Center- Pre-Screening Step ❻ Investigator Account Reach Patient Establish Contact Pre-Screen Refer Randomize 24

25 sites don t like it 25

26 sites don t like it 26

27 sites don t like it Web Web Responses / Clicks Trial / DB Registrations (100%) ~ DB Reg s ~ Responses / Clicks ~ Online Pre-Screenings (60%) 4. x Call Center Screening (outbound, N/A) pre-qualified referrals (33%) % expected enrollment referrals Pre-Screens Minimum Workload / Site (if ~200 out of ~400): = ~ 30 pre-qualified referrals / Site = ~ 10 pre-qualified referrals / Site / Month 30 Referrals / Site = Feasible Funnel calculated on 8 previous outreach campaigns / projects in EUROPE, 4 countries, adapted to protocol specifics No US campaigns included 27

28 ...my patients aren't on the internet we've already done online recruitment and it doesn't work sites don't like it, low quality of patients online patient recruitment only works in certain countries Agenda 28

29 is e-recruitment doable internationally? HU Hungary Western Europe # www (in Millions) % (Penetration) Hungary 9,9 6,5 65,4 % Visits Studies % 872, ClinLife Regional Distribution Visits & Page views 2013 Visits Pageviews % North America 3,018,986 4,207, % Western Europe 2,702,638 4,627, % Eastern Europe 1,611,798 2,129, % South America 555, ,745 7 % APAC 207, ,898 3 % Africa 178, ,773 2 % TOTAL 8,274,927 12,208, % ZA South Africa - Africa # www (in Millions) % (Penetration) Africa 48,8 8,5 17,4 Visits Studies % 178,

30 is e-recruitment doable internationally? ClinLife Regional Distribution Visits & Page views 2013 Visits Pageviews % North America 3,018,986 4,207, % Western Europe 2,702,638 4,627, % Eastern Europe 1,611,798 2,129, % South America 555, ,745 7 % APAC 207, ,898 3 % Africa 178, ,773 2 % TOTAL 8,274,927 12,208, % Argentina South America # www (in Millions) % (Penetration) Argentina 41,7 28,0 67,0 Visits Studies % 449,

31 QUESTIONS? Nils Drews, MD CMO, Executive VP Clariness GmbH Rütersbarg 46 D Hamburg Germany Phone: +49-(0) Fax: +49-(0) Mobile: +49-(0) Web:

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